Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)
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ClinicalTrials.gov Identifier: NCT01771341 |
Recruitment Status
:
Completed
First Posted
: January 18, 2013
Last Update Posted
: January 22, 2015
|
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Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.
This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patient-ventilator Asynchronism | Device: MAQUET SERVOi ventilator with Edi Catheter Device: MAQUET SERVOi ventilator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support) |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Pressure support |
Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
|
Experimental: NAVA |
Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist
|
- Asynchrony index (AI) [ Time Frame: 8 hours ]Number of asynchrony events/total respiratory rate
- PaO2/FiO2 ratio [ Time Frame: 8 hours ]ratio of partial pressure arterial oxygen and fraction of inspired oxygen

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult > 18 yr-old
- abdominal post-operative patient
- able to trigger the ventilator
Exclusion Criteria:
- infant
- pregnancy
- esophageal surgery
- recent esophageal variceal bleeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771341
France | |
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud | |
Pierre Bénite, France, 69310 |
Principal Investigator: | Florent WALLET, MD | Hospices Civils de Lyon |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT01771341 History of Changes |
Other Study ID Numbers: |
2010.646 |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | January 22, 2015 |
Last Verified: | January 2015 |
Keywords provided by Hospices Civils de Lyon:
NAVA post operative |